Professional Development

Federal Register Summary for week of 22 June 2018

Commerce

62nd Meeting of the NOAA Science Advisory Board

AGENCY: Office of Oceanic and Atmospheric Research (OAR), National
Oceanic and Atmospheric Administration (NOAA), Department of Commerce
(DOC).

ACTION: Notice of public meeting.

SUMMARY: This notice sets forth the schedule and proposed agenda of a
meeting of the NOAA Science Advisory Board (SAB). The members will
discuss issues outlined in the section on Matters to be considered.

DATES: The meeting will be held Tuesday, July 17, 2018 from 9:45 a.m.
EDT to 5:00 p.m. EDT and on Wednesday, July 18, 2018 from 9 a.m. EDT to
12 p.m. EDT. These times and agenda topics described below are subject
to change. For the latest agenda please refer to the SAB website:
http://sab.noaa.gov/SABMeetings.aspx.

Environmental Protection Agency

National Advisory Council for Environmental Policy and Technology; Renewal of Charter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of charter renewal.

SUMMARY: Notice is hereby given that the Environmental Protection
Agency (EPA) has determined that, in accordance with the provisions of
the Federal Advisory Committee Act (FACA), the National Advisory
Council for Environmental Policy and Technology (NACEPT) is necessary
and in the public interest in connection with the performance of duties
imposed on the agency by law. Accordingly, NACEPT will be renewed for
an additional two-year period. The purpose of NACEPT is to provide
advice and recommendations to the Administrator of EPA on a broad range
of environmental policy, technology and management issues.

Executive Office of the President

Executive Order 13840--Ocean Policy To Advance the Economic, Security, and Environmental Interests of the United States

By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:

Section 1. Purpose. The ocean, coastal, and Great Lakes
waters of the United States are foundational to the
economy, security, global competitiveness, and well-
being of the United States. Ocean industries employ
millions of Americans and support a strong national
economy. Domestic energy production from Federal waters
strengthens the Nation's security and reduces reliance
on imported energy. Our Armed Forces protect our
national interests in the ocean and along the Nation's
coasts. Goods and materials that support our economy
and quality of life flow through maritime commerce. Our
fisheries resources help feed the Nation and present
tremendous export opportunities. Clean, healthy waters
support fishing, boating, and other recreational
opportunities for all Americans.

This order maintains and enhances these and other
benefits to the Nation through improved public access
to marine data and information, efficient interagency
coordination on ocean-related matters, and engagement
with marine industries, the science and technology
community, and other ocean stakeholders. To advance
these national interests, this order recognizes and
supports Federal participation in regional ocean
partnerships, to the extent appropriate and consistent
with national security interests and statutory
authorities.

Sec. 2. Policy. It shall be the policy of the United
States to:

(a) coordinate the activities of executive
departments and agencies (agencies) regarding ocean-
related matters to ensure effective management of
ocean, coastal, and Great Lakes waters and to provide
economic, security, and environmental benefits for
present and future generations of Americans;

(b) continue to promote the lawful use of the ocean
by agencies, including United States Armed Forces;

(c) exercise rights and jurisdiction and perform
duties in accordance with applicable domestic law and--
if consistent with applicable domestic law--
international law, including customary international
law;

(e) ensure that Federal regulations and management
decisions do not prevent productive and sustainable use
of ocean, coastal, and Great Lakes waters;

(f) modernize the acquisition, distribution, and
use of the best available ocean-related science and
knowledge, in partnership with marine industries; the
ocean science and technology community; State, tribal,
and local governments; and other ocean stakeholders, to
inform decisions and enhance entrepreneurial
opportunity; and

(g) facilitate, as appropriate, coordination,
consultation, and collaboration regarding ocean-related
matters, consistent with applicable law, among Federal,
State, tribal, and local governments, marine
industries, the ocean science
and technology community, other ocean stakeholders, and
foreign governments and international organizations.

Sec. 3. Definitions. For the purposes of this order,
the following definitions apply:

(a) "Ocean-related matters" means management,
science, and technology matters involving the ocean,
coastal, and Great Lakes waters of the United States
(including its territories and possessions), and
related seabed, subsoil, waters superadjacent to the
seabed, and natural resources.

(b) "Regional ocean partnership" means a regional
organization of coastal or Great Lakes States,
territories, or possessions voluntarily convened by
governors to address cross-jurisdictional ocean
matters, or the functional equivalent of such a
regional ocean organization designated by the governor
or governors of a State or States.

Sec. 4. Interagency Coordination.

(a) To ensure
appropriate coordination by Federal agencies on ocean-
related matters, there is hereby established the
interagency Ocean Policy Committee (Committee).

(i) The Committee shall consist of the following:

(1) The Chairman of the Council on Environmental Quality (CEQ) and the
Director of the Office of Science and Technology Policy (OSTP), who shall
serve as Co-Chairs;

(2) The Secretary of State, Secretary of Defense, Attorney General,
Secretary of the Interior, Secretary of Agriculture, Secretary of Commerce,
Secretary of Transportation, Secretary of Energy, Secretary of Homeland
Security, Administrator of the Environmental Protection Agency, Director of
the Office of Management and Budget, Administrator of the National
Aeronautics and Space Administration, Director of the National Science
Foundation, Director of National Intelligence, Chairman of the Joint Chiefs
of Staff, Under Secretary of Commerce for Oceans and Atmosphere, Assistant
Secretary of the Army (Civil Works), and Commandant of the Coast Guard;

(3) The Assistants to the President for National Security Affairs,
Homeland Security and Counterterrorism, Domestic Policy, and Economic
Policy;

(4) A representative from the Office of the Vice President designated by
the Vice President; and

(5) Such other officers or employees of the Federal Government as the Co-
Chairs may from time to time designate.

(b) The Co-Chairs, in coordination with the
Assistants to the President for National Security
Affairs, Homeland Security and Counterterrorism,
Domestic Policy, and Economic Policy, shall regularly
convene and preside at meetings of the Committee,
determine its agenda, and direct its work, and shall
establish and direct subcommittees of the Committee as
appropriate. The Committee shall, as appropriate,
establish subcommittees with responsibility for
advising the Committee on matters pertaining to ocean
science and technology and ocean-resource management.

(i) Committee members may designate, to perform their Committee or
subcommittee functions, any person who is within their department, agency,
or office who is:

(1) a civilian official appointed by the President;

(2) a member of the Senior Executive Service or the Senior Intelligence
Service;

(3) a general officer or flag officer; or

(4) an employee of the Office of the Vice President.

(ii) Consistent with applicable law and subject to the availability of
appropriations, OSTP or CEQ shall provide the Committee with funding,
including through the National Science and Technology Council pursuant to
title VII, section 723 of the Consolidated Appropriations Act, 2018 (Public
Law 115-141), or any successor provision, or through the Office of
Environmental Quality pursuant to the Office of Environmental Quality
Management Fund, 42 U.S.C. 4375. OSTP or CEQ shall, to the extent permitted
by law and subject to the availability of appropriations, provide
administrative support as needed to implement this order.

(iii) The Committee shall be administered by an Executive Director and such
full-time staff as the Co-Chairs recommend.

Sec. 5. Functions. To implement the policy set forth in
section 2 of this order, the Committee shall, to the
extent permitted by law:

(b) engage and collaborate, under existing laws and
regulations, with stakeholders, including regional
ocean partnerships, to address ocean-related matters
that may require interagency or intergovernmental
solutions;

(c) coordinate the timely public release of
unclassified data and other information related to the
ocean, coasts, and Great Lakes that agencies collect,
and support the common information management systems,
such as the Marine Cadastre, that organize and
disseminate this information;

(d) coordinate and inform the ocean policy-making
process and identify priority ocean research and
technology needs, to facilitate:

(i) the use of science in the establishment of policy; and

(ii) the collection, development, dissemination, and exchange of
information between and among agencies on ocean-related matters;

(e) coordinate and ensure Federal participation in
projects conducted under the National Oceanographic
Partnership Program through the Committee's members, as
appropriate, to maximize the effectiveness of agency
investments in ocean research; and

Sec. 6. Cooperation. To the extent permitted by law,
agencies shall cooperate with the Committee and provide
it such information as it, through the Co-Chairs, may
request. The Committee shall base its decisions on the
consensus of its members. With respect to those matters
for which consensus cannot be reached, the Assistant to
the President for National Security Affairs shall
coordinate with the Co-Chairs to present the disputed
issue or issues for decision by the President. Within
90 days of the date of this order, agencies shall
review their regulations, guidance, and policies for
consistency with this order, and shall consult with
CEQ, OSTP, and the Office of Management and Budget
(OMB) regarding any modifications, revisions, or
rescissions of any regulations, guidance, or policies
necessary to comply with this order.

Sec. 7. Revocation. Executive Order 13547 of July 19,
2010 (Stewardship of the Ocean, Our Coasts, and the
Great Lakes), is hereby revoked.

Sec. 8. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department, agency, or the
head thereof;

(ii) the functions of the Director of OMB relating to budgetary,
administrative, or legislative proposals; or

(iii) functions assigned by the President to the National Security Council
or Homeland Security Council (including subordinate bodies) relating to
matters affecting foreign affairs, national security, homeland security, or
intelligence.

(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.

(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.

Health and Human Services

Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Antimicrobial Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held on August 8, 2018, from 8:30 a.m. to 1
p.m.

FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-1073. The docket will close on August
7, 2018. Submit either electronic or written comments on this public
meeting by August 7, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before August 7, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of August 7, 2018. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Comments received on or before July 24, 2018, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see "Written/Paper Submissions" and "Instructions").

For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in "Instructions."

Instructions: All submissions received must include the Docket No.
FDA-2018-N-1073 for "Antimicrobial Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments."
Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as "Confidential
Submissions," publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.

Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
"THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as "confidential." Any
information marked as "confidential" will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the "Search" box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax: 301-847-8533, email: AMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

Office of the Director, National Institutes of Health; Notice of Meeting

Pursuant to section 10(a) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
Office of AIDS Research Advisory Council.

The meeting will be open to the public, with attendance limited to
space available. Individuals who plan to attend and need special
assistance, such as sign language interpretation or other reasonable
accommodations, should notify the Contact Person listed below in
advance of the meeting.

Any interested participants are encouraged to join this meeting
at the weblink provided, at least 30 minutes prior to the scheduled
start time. Information is also available on the Institute's/
Center's home page: www.oar.nih.gov, where an agenda and any
additional information for the meeting will be posted when
available.

National Science Foundation

Request for Information--Environmental Research and Education, National Security, and Economic Competitiveness

AGENCY: National Science Foundation.

ACTION: Notice of Request for Information.

SUMMARY: The purpose of this Request for Information (RFI) is to seek
input from the public on possible future directions for fundamental
environmental science and education. The RFI intends to gather views
from external stakeholders on what environmental research and education
is needed to further advance national security and economic
competitiveness. NSF's Advisory Committee for Environmental Research
and Education (AC ERE) will use the input to develop a report on these
topics to inform NSF and the community.

Sunshine Act Meeting; National Science Board

The National Science Board, pursuant to NSF regulations (45 CFR
part 614), the National Science Foundation Act, as amended (42 U.S.C.
1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b),
hereby gives notice of
the scheduling of a teleconference for the transaction of National
Science Board business, as follows:

TIME AND DATE: Open meeting of the Executive Committee of the National
Science Board, to be held Friday, June 22, 2018, from 4:00-5:00 p.m.
EDT.

PLACE: This meeting will be held by teleconference at the National
Science Foundation, 2415 Eisenhower Ave., Alexandria, VA 22314.

STATUS: Open.

MATTERS TO BE CONSIDERED: Committee Chair's Opening Remarks; approval
of Executive Committee Minutes of April 2, 2018; discuss issues and
topics for an agenda of the NSB Meeting scheduled for July 17-18, 2018.

CONTACT PERSON FOR MORE INFORMATION: Point of contact for this meeting
is: James Hamos, 2415 Eisenhower Ave., Alexandria, VA 22314. Telephone:
(703) 292-8000.